A randomised, crossover, clinical study to assess nicotine pharmacokinetics and subjective effects of the BIDI® stick ENDS compared with combustible cigarettes and a comparator ENDS in adult smokers

Abstract

Background

Nicotine pharmacokinetic assessments of electronic nicotine delivery systems (ENDS) are crucial to understand their ability to provide an alternative to cigarette smoking. Subjective effects data also strongly contribute to this understanding. The BIDI^® Stick is a disposable ENDS product which contains 59 mg/ml nicotine benzoate salt and various flavours.

Methods

In this study, we assessed nicotine pharmacokinetics and subjective effects of 6 flavour variants of BIDI^® Stick ENDS in adult smokers, compared to cigarettes and a comparator ENDS product. During each of eight study visits, 18 volunteer smoker subjects randomly used one of either their usual brand (UB) of cigarette, a BIDI^® Stick ENDS, or a comparator ENDS (JUUL 59 mg/ml nicotine with Virginia Tobacco flavour), during both controlled (10 puffs, 30 s apart) and ad libitum (60 min) puffing sessions. Blood samples were collected at various time points and subjective effects questionnaires were administered.

Results

Mean [SD] plasma nicotine C_{max 0–120} was not significantly different between BIDI^® Stick ENDS with any flavour (range 15.3 [9.90] ng/ml for BIDI^® Stick Winter to 17.6 [9.00] ng/ml for BIDI^® Stick Classic) and UB cigarettes (16.2 [9.17] ng/ml). Mean [SD] AUC_0-120 (range 569.7 [327.29] to 628.6 [408.99] min*ng/ml for BIDI^® Stick ENDS and 747.1 [325.48] min*ng/ml for UB cigarettes) and median T_{max 0–120} (range 5-7 min for all BIDI^® Stick ENDS and UB cigarettes) values were also not significantly different between BIDI^® Stick ENDS and UB cigarettes, while subjective effects measures were also similar between BIDI^® Stick ENDS and UB cigarettes. Mean [SD] plasma nicotine C_{max 0–120}, AUC_0-120, and median T_{max 0–120} were 6.8 [4.13] ng/ml, 243.6 [179.04] min*ng/ml, and 5 min, respectively, for JUUL ENDS. These values were significantly different compared with those for all BIDI^® Stick ENDS and UB cigarettes for both C_{max 0–120} and AUC_0-120 but not for T_{max 0–120}.

Conclusions

BIDI^® Stick ENDS delivered nicotine to users comparably to their UB combustible cigarette and higher than JUUL ENDS, and also elicited similar subjective effects such as satisfaction and relief. Thus, the BIDI^® Stick ENDS may be a satisfying alternative to cigarettes among current smokers and may support their transitioning away from cigarette smoking.

Trial registration

ClinicalTrials.gov (identifier number NCT05072925).